Sponsors: The National Institute of Mental Health (NIMH) and The HIV Prevention Trials Network (HPTN 043)

Study Objectives

The primary objective of this study is to test the hypothesis that communities receiving three years of the community-based HIV voluntary counseling and testing (CBVCT) intervention, relative to communities receiving three years of standard clinic-based VCT (SVCT), will have significantly lower incidence of recent HIV infection.

Aim 1 will be evaluated by comparing the post-intervention incidence of recent HIV infection in 24 intervention and 24 comparison communities, using an algorithmic approach comprised of CD4+ T-cell counts, the HIV-1 BED Incidence EIA (Calypte), Avidity Index (BioRad), and HPLC for ART residues (HPTN Core Lab/JHU). A combination of all these markers contains more information on infection duration than any single component.

The secondary objective of this study is to test the hypotheses that intervention communities, relative to comparison communities, will at the end of the intervention period report significantly less HIV risk behavior, higher rates of HIV testing, more favorable social norms regarding HIV testing, more frequent discussions about HIV, more frequent disclosure of HIV status, less HIV-related stigma, fewer HIV-related negative life events.

The Intervention

The NIMH Project Accept intervention consists of four main components: community mobilization, Community-Based (mobile) VCT, post-test support services and feedback of utilization rates and quality of the intervention. The intervention in each of the countries and sites is derived from the same theoretical model and contain the same strategies. The implementation of the elements of the intervention is tailored to each local culture and context. The intervention is based on the premise that HIV sexual risk behavior and HIV incidence will decrease in communities with increased knowledge of HIV status and more supportive community norms.

Communities randomized to Standard VCT (the "standard-of-care") will only receive the installment of clinic-based VCT services at existing facilities. The training for VCT counselors will be the same in the intervention and comparison communities; however, no active outreach/community mobilization, mobile/enhanced-access VCT services, or special post-test clubs will be provided in the comparison communities.

Communities randomized to intervention will receive, in addition to the standard VCT services, four components of the Project Accept intervention.

For a detailed description of the Project Accept intervention, please refer to the following publication:

This component of the intervention is based on diffusion of innovation theory, which contends that there are a small number of people in communities who are innovators. Then, early adopters influence others in a social network. Eventually, a threshold of behavioral adoption at the network level is reached that sustains the widespread uptake of a behavior. This is similar to what would be explained by the "law of the few" in tipping theory, but puts greater emphasis on the importance of timing. In particular, diffusion of innovation theory would predict that by enticing opinion leaders early on to adopt an innovative behavior deemed to be adaptive, the speed of uptake of the new behavior is facilitated. Thus, a community mobilization approach that promotes HIV testing among early adopters, particularly if these individuals are influential and central to the larger social network, can begin a process of changing community norms to both increase discussions about HIV in communities and decrease HIV-related stigma.

Community mobilization uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV. This component is also designed to reduce stigma through community education and mobilization. The community mobilization phase of the intervention consists of educating communities about HIV, providing HIV testing, and encouraging discussion in the community with the intent to increase awareness and decrease stigma. Ultimately, these efforts are intended to increase acceptance and utilization of the mobile VCT component of the study.

Easy Access to VCT

This component of the intervention is based on tipping point theory and is designed to remove practical barriers (fees, inconvenience, and the need to return for results) and increase safety of VCT (anonymity, high-quality counseling and post-test support). This ease of access is designed to increase rates of HIV testing, change social norms about testing, and increase the frequency of discussions about HIV in communities. This approach should also decrease behavioral risk for HIV. Mobile vans or temporary units set up at local community sites provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers.

Post-Test Support Services

The third component of the intervention is based on a social action model and is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV. The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission. Our objective in providing post-test support services (PTSS) is to create a culturally appropriate support system for community members following their decision to test for HIV.

Feedback--Utilization Rates and Quality Assurance

Throughout the intervention feedback on utilization of the various components has been monitored and feedback provided to intervention field staff. This has allowed those implementing the project to make adjustments in the day-to-day operations to increase participation. In addition, quality assurance procedures were instituted at all sites and this feedback was important for maintaining fidelity to the intervention.

Comparison Communities

In comparison communities, standard VCT services are provided at existing district hospitals, community-based health care centers, or other local health delivery facilities. The procedures for counseling and HIV rapid testing are the same as those in the intervention communities, except that referrals will be limited to existing community agencies rather than study-related post-test support services.

In the first year of the study, a four-fold increase in testing was observed in the intervention versus comparison communities. We also found an overall 95% adherence to intervention components. Study outcomes, including prevalence of recent HIV infection and community-level HIV stigma, are currently being assessed.

Project Sites

The NIMH Project Accept is a multisite, community randomized intervention trial being conducted at 5 sites in 4 different countries.

The Tanzania site is in Kisarawe district, a rural coastal region approximately 100 km from Dar es Salaam adjacent to a major transit route. The area is largely agricultural and the project is locally referred to as Project Afiki.

The Thailand site is in the Chiang Mai Northern province, with communities located in rural areas near the border with Myanmar, largely populated by ethnic minorities. The project is locally referred to as PA-Thai Project.

The Zimbabwe site is in Mutoko, a rural district located in the Mashonaland East province, approximately 150 km from the capital, Harare, a largely agricultural area. The project is locally referred to as CBVCT Project.

The Vulindlela site is in South Africa, KwaZulu-Natal province, a rural area located approximately 25 km from Pietermaritzburg. Employment opportunities are provided mostly through the forestry industry and in nearby towns. The project is locally referred to as Ukwamukela Project.

The second South African site is in Soweto, in the Gauteng province, the largest urban township in South Africa, historically created to accommodate the work force for the city of Johannesburg. The project is locally referred to as PHRU Project Accept.